NCT01673139

Brief Summary

This is a substudy of "Generation 100". The investigators will follow the persons with atrial fibrillation to see if 3 years of interval or moderate exercise affects the burden of atrial fibrillation, symptoms, use of health services or echocardiographic findings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

5.9 years

First QC Date

August 22, 2012

Last Update Submit

November 16, 2018

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationExercise

Outcome Measures

Primary Outcomes (1)

  • Change in burden of atrial fibrillation

    Burden of atrial fibrillation; measured by Holter monitor and the patient.

    At baseline and 3 years

Secondary Outcomes (13)

  • Size of left ventricle

    At baseline and 3 years

  • Quality of life

    At baseline and 3 years

  • Endothelial function

    At baseline and 3 years

  • Maximal oxygen uptake

    At baseline and 3 years

  • Atrial extrasystoles

    At baseline and 3 years

  • +8 more secondary outcomes

Study Arms (3)

Moderate exercise

EXPERIMENTAL

Moderate exercise

Behavioral: Moderate exercise

Control

EXPERIMENTAL

Control group

Behavioral: Control

Interval exercise

EXPERIMENTAL

interval exercise

Behavioral: Interval exercise

Interventions

Interval exerciseBEHAVIORAL

4 times of 4 minutes intervals at an intensity of 90-95% of maximum heart rate and active pauses of 3 minutes between intervals. 3 times a week for 3 years.

Interval exercise
Moderate exerciseBEHAVIORAL

Moderate exercise with pulse about 70% of max pulse; 3 times a week for 3 years.

Moderate exercise
ControlBEHAVIORAL

Given information on recommendations for physical activity.

Control

Eligibility Criteria

Age70 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Included in the "Generation 100 study"
  • Atrial fibrillation diagnosis verified by ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7491, Norway

Location

MeSH Terms

Conditions

Atrial FibrillationMotor Activity

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Jan Paal Loennechen, PhD

    St. Olavs Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2012

First Posted

August 27, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 19, 2018

Record last verified: 2018-11

Locations

NO(1)